Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Pain Management I: Spinal-Cord Stim To Grab Ever-Bigger Market Share

The field of neuromodulation for treating chronic pain is growing rapidly, especially in the fastest-growing spinal cord stimulation (SCS) market segment, which is expected to hit $2.4bn by 2021. This article, the first of a two-part series, will explore what the key drivers and limitations are for the SCS market and provide insight from three established pain management specialists on what factors will push wider adoption of this therapy.

Neurology Market Intelligence Commercial

45% Leap In Notified-Body Certificates Withdrawn From Device Firms

2016 saw the largest single-year rise in the number of EU certificates that were withdrawn from device companies by members of the TEAM-NB notified body association. The specific causes of the withdrawals varied, but increased regulatory expectations in the EU are likely an important factor.

Medical Device Europe Regulation

EuroPCR 2017: TAVR Continues To Beat Surgery; Bioabsorbable Stents Not Going Away

The EuroPCR conference in Paris is the most important annual interventional cardiology conference in Europe and this year's edition brought more data from clinical trials of both established catheter-based technologies and innovative new devices.

Cardiology Clinical Trials Innovation

Device Week – May 19, 2017

On this week's Medtech Insight podcast: ex-US FDA Commissioner Bob Califf talks new commish and Trump; the latest on the Food and Drug Administration Reauthorization Act (FDARA); FDA recommends approval for the TransMedics Organ Care System; blood lead tests made by Magellan Diagnostics may give bad results; updates from the Heart Rhythm Society Scientific Sessions in Chicago and EuroPCR 2017 in France.

FDA Medical Device United States
Advertisement


Recent Tweets from Medtech Insight


Policy & Regulation Explore this Topic

Set Alert for Policy

NEST Executive Director: A One Woman Army

The National Evaluation System for health Technology, which FDA officials have said will re-make device data collection in the US, is finally getting off the ground. Rachael Fleurence took the helm last month as the executive director for the NEST Coordinating Center. In a podcast interview with Medtech Insight, Fleurence talks about her qualifications, and what she hopes the project will accomplish within the next year, and beyond.

Clinical Trials Comparative Effectiveness Innovation

Q1 Recalls Snapshot: Recalled Device Units Drop To Lowest Level Since 2013; Recall Events Dip Slightly

There were 284 recall events from January through March, down 9% from Q4 2016's 313 corrections and removals. Check out our Q1 recalls infographic.

Recalls Quality Control Medical Device

Abbott Catheter Recall Designated As Class I

A tight balloon sheath in some Abbott coronary catheters has been linked to adverse events including air embolism, thrombosis, heart attack and death. Almost 450,000 units are being recalled worldwide.

Recalls Safety

TGA Consults On Ground Rules For Identifying ‘Comparable’ Regulators To Reduce Duplication

Australia has proposed criteria against which it plans to evaluate overseas regulators to ascertain if their standards are comparable, and whether their assessment reports can be used to support inclusion of medical devices on the Australian Register of Therapeutic Goods. Also, there are plans to develop work-sharing arrangements with comparable regulators on a case-by-case basis.

Regulation Australia

Senators To Trump Administration: 'Way Too Late' To Change US FDA Budget Structure Now

Senate HELP Committee leaders Lamar Alexander, R-Tenn., and Patty Murray, D-Wash., said it's "way too late" for Congress to alter the budgetary balance between device and drug industry US FDA user-fee contributions and congressional appropriations for the upcoming 2018-2022 user-fee cycle in tersely worded statements to HHS Secretary Tom Price May 16.

Legislation Medical Device

Number To Know…2

Two more bills have been introduced in the US House to streamline the FDA device review process.

United States Regulation

House Subcommittee OK's FDA User Fee Bill; More Debate On Third-Party Servicers To Come

The House Energy and Commerce Health Subcommittee passed a bill reauthorizing FDA's device user fees May 18, along with amendments on over-the-counter (OTC) hearing aids and to streamline agency inspections of device facilities, among others. The subpanel agreed to shelve – for now – a proposed bill to facilitate off-label communications by medical product firms, and said they will wait for the full committee markup to debate a third-party servicers bill backed by imaging firms.

Policy & Regulation Legislation

More Review-Streamliners Introduced In US House: Can They Beat User-Fee Buzzer?

Two more bills were introduced in the House this week to streamline US FDA device review. Its late in the game, but device lobbyists are not completely ruling out attachments to must-pass user-fee bills. Also, check out our table rounding up FDA medtech reform bills that are circulating in Congress.

Legislation Policy

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Latest From Quality Control

More Review-Streamliners Introduced In US House: Can They Beat User-Fee Buzzer?

Two more bills were introduced in the House this week to streamline US FDA device review. Its late in the game, but device lobbyists are not completely ruling out attachments to must-pass user-fee bills. Also, check out our table rounding up FDA medtech reform bills that are circulating in Congress.

Legislation Policy

Singapore Consults On Implementing New Device Distribution Standard

Singapore’s Health Sciences Authority is inviting feedback on a draft guideline to help medical device importers and wholesalers comply with its new standard on good distribution practice. The earlier technical specification on this topic will be phased out by 2020.

Regulation Quality Control

'Your Ombuddy': ORA's New Ombudsman Doesn't Want Device Firms To Be Terrified Of Her

When you pick up the phone to contact US FDA, do you sweat? That's exactly the type of response that Jessica Zeller, the very first ombudsman for the agency's Office of Regulatory Affairs, wants to avoid. "I know you're terrified to call," Zeller says, but she wants industry to know that she considers herself to be an "ombuddy" to manufacturers.

FDA Compliance

Commercial Explore this Topic

Set Alert for Commercial

EuroPCR 2017: Robocath Eyes H1 2018 Robotic Catheterization System Launch With New Funds

Emerging medical robotics firm Robocath has raised fresh funds to take its R-one system through clinical trials and into the market by the first half of next year.

Cardiology Cardiovascular StartUps and SMEs

Latest From Commercial

New Acquisition And Positive Data Inflates Philips' Respiratory Biz

Philips has expanded its sleep and respiratory care unit with the acquisition of US firm Respiratory Technologies, Inc., which offers a noninvasive airway clearance solution for patients with chronic respiratory problems. Separately, as an additional boost to this business, a clinical study sponsored by the Dutch multinational gave further support for the combined used of home noninvasive ventilation with oxygen therapy to delay hospital readmissions in COPD patients.

Respiratory M & A

vitalityDNA Plans To Keep Healthy People Healthy

vitalityDNA is taking the preventative approach to health care with its personalized health and lifestyle plan offering. The start-up will initially target consumers and then health care companies.

In Vitro Diagnostics StartUps and SMEs

WannaCry Cybersecurity Alert Shows Medtech Software Must Look Beyond Quick Fixes

Preventing cyberattacks on medical technology occupies the waking thoughts of device software manufacturers, but the global ransomware episode in mid-May shows that companies must also be alive to threat posed to their provider customers.

Digital Health Commercial

Philips' Survey Highlights Gaps In Perceptions Of Health Care

Connected care technologies play an important role in disease prevention, but are still not used as widely as they should be. Philips' second Future Health Index study surveyed 33,000 participants in 19 countries to compare perceptions and experiences of healthcare users across three areas - access to care, integration of health systems and adoption of connected care technologies.

Digital Health Commercial

Device Exec Pleads Guilty To Trade Secret Theft

Christopher Barry, a former VP of R&D at Bard subsidiary Lutonix, pleaded guilty to one count of theft of trade secrets. He now faces up to two and a half years in prison.

Legal Issues Intellectual Property

Senseonics, TypeZero Join Forces On Artificial Pancreas

Diabetes companies Senseonics and TypeZero Technologies have signed a research and development licensing agreement to develop an artificial pancreas.

Metabolic Disorders Diabetic Care

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

EuroPCR 2017: Xeltis' Regenerated Heart Valve Shows Promising Early Preclinical Data

It may still be early days but Xeltis' second product from its Endogenous Tissue Restoration platform technology, an aortic valve scaffold, is showing promising results in animal studies. The data, presented at EuroPCR, showed that the bioresorbable aortic valve had good hemodynamic performance and fully functional valves in vivo six months after implantation.

StartUps and SMEs Research & Development Clinical Trials

Latest From Research & Development

New Acquisition And Positive Data Inflates Philips' Respiratory Biz

Philips has expanded its sleep and respiratory care unit with the acquisition of US firm Respiratory Technologies, Inc., which offers a noninvasive airway clearance solution for patients with chronic respiratory problems. Separately, as an additional boost to this business, a clinical study sponsored by the Dutch multinational gave further support for the combined used of home noninvasive ventilation with oxygen therapy to delay hospital readmissions in COPD patients.

Respiratory M & A

INS 2017 Aims To Offer Sneak Peek Into Future Neuromodulation Trends

As scientific and industry experts prepare to gather in Edinburgh, Scotland, later this month for the 13th International Neuromodulation Society Congress, Medtech Insight spoke to Timothy Deer, INS president and a pain-management specialist, about what's ahead in neuromodulation and what to expect at the meeting.

Research & Development Innovation

HRS 2017: EBR's Leadless CRT Feasibility; Watchman Registry Data; A Novel AF Ablation Catheter From BW; And More Medtronic CRT Data

Results from "real-world" registries of established devices, along with encouraging early results from novel devices were among the highlights of Heart Rhythm 2017, the annual scientific sessions of the Heart Rhythm Society, held in Chicago May 10-13.

Cardiology Clinical Trials

EuroPCR 2017: Boston Scientific's Lotus TAVR Beats Medtronic's CoreValve In REPRISE III, But Pacemaker Issue Remains

Boston Scientific's repositionable, mechanically expanded Lotus transcatheter aortic valve performed better than Medtronic's CoreValve for the primary composite effectiveness endpoint in the REPRISE III trial, according to results presented at the EuroPCR meeting in Paris. But the Lotus patients in the trial were more likely to need a pacemaker than the CoreValve patients, a risk that investigators believe can be mitigated with better operator technique.

Cardiology Clinical Trials

HRS 2017: Medtronic And Boston Scientific's Less-Invasive CRM Devices Perform As Hoped In Real-World Registries

Results from the post-approval trials of Medtronic's Micra Transcatheter Pacing System and Boston Scientific's S-ICD presented at the Heart Rhythm Society Scientific Sessions in Chicago show these "leadless" devices can be implanted in "real world" patients with acute outcomes similar to those of the pre-market trials that had more restrictive inclusion criteria.

Clinical Trials Research & Development

OUS Approvals Analysis: Small Companies Dominate International Approvals In April

April was a return to a more typical volume of medical device approvals outside the US after a particularly busy March. And the big names in medtech were mostly quiet in April's OUS approvals, according to Medtech Insight's Approval Tracker.

Approvals Innovation
UsernamePublicRestriction

Register